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A randomized controlled trial protocol assessing the effectiveness, safety and cost‐effectiveness of methotrexate vs. ciclosporin in the treatment of severe atopic eczema in children: the TRE atment of severe Atopic eczema Trial ( TREAT )
Author(s) -
Irvine A.D.,
Jones A.P.,
Beattie P.,
Baron S.,
Browne F.,
Ashoor F.,
O'Neill L.,
RosalaHallas A.,
Sach T.,
Spowart C.,
Taams L.,
Walker C.,
Wan M.,
Webb N.,
Williamson P.,
Flohr C.
Publication year - 2018
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.16717
Subject(s) - medicine , randomized controlled trial , ciclosporin , atopic dermatitis , scorad , methotrexate , quality of life (healthcare) , adverse effect , clinical trial , dermatology life quality index , pediatrics , physical therapy , dermatology , transplantation , disease , nursing
Summary Background Oral systemic immunomodulatory medication is regularly used off‐licence in children with severe atopic eczema. However, there is no firm evidence regarding the effectiveness, safety, cost‐effectiveness and impact on quality of life from an adequately powered randomized controlled trial ( RCT ) using systemic medication in children. Objectives To assess whether there is a difference in the speed of onset, effectiveness, side‐effect profile and reduction in flares post‐treatment between ciclosporin (CyA) and methotrexate ( MTX ), and also the cost‐effectiveness of the drugs. Treatment impact on quality of life will also be examined in addition to whether FLG genotype influences treatment response. In addition, the trial studies the immune–metabolic effects of CyA and MTX . Methods Multicentre, parallel group, assessor‐blind, pragmatic RCT of 36 weeks’ duration with a 24‐week follow‐up period. In total, 102 children aged 2–16 years with moderate‐to‐severe atopic eczema, unresponsive to topical treatment will be randomized (1 : 1) to receive MTX (0·4 mg kg −1 per week) or CyA (4 mg kg −1 per day). Results The trial has two primary outcomes: change from baseline to 12 weeks in Objective Severity Scoring of Atopic Dermatitis (o‐ SCORAD ) and time to first significant flare following treatment cessation. Conclusions This trial addresses important therapeutic questions, highlighted in systematic reviews and treatment guidelines for atopic eczema. The trial design is pragmatic to reflect current clinical practice.